Study of Inflammatory and Physiological Profiles of Healthy and Diseased Lung

NCT ID: NCT06144476

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-08

Study Completion Date

2029-08-31

Brief Summary

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There are over 700,000 UK hospital admissions every year with lung disease symptoms. Two of the most common lung diseases contributing to these numbers are asthma and chronic obstructive pulmonary disease (COPD). The immunopathology of these diseases is not fully understood. Matched samples from the respiratory tract and circulation will be used to identify immune patterns throughout the respiratory system to elucidate the immunopathology of airway disease.

Detailed Description

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In this observational study, we will be enrolling patients with diagnosed or suspected airways disease who are over 18 years old, as well as age matched healthy volunteers with no significant illness. Participants will be asked if they consent to enter the study, invited at clinically relevant time points (treatment change, disease exacerbation etc.) and to optional bronchoscopy visits. It is expected that participants will be seen yearly with any additional exacerbation/treatment visits also recorded. Research visits will occur at King's College London and the Guys and St Thomas' NHS Foundation Trust (GSTFT), with all bronchoscopy visits occurring within GSTFT

1. Disease specific questionnaires.
2. Lung function tests including spirometry or oscillometry (if not performed previously within 6 months)
3. Sputum collection
4. Nasal sampling including nasosorption, nasal brushing, nasal lavage, or nasopharyngeal swabs
5. Exhaled breath
6. Blood samples (\<6 tablespoons)

Optional
7. Bronchoscopy involving a flexible fibreoptic camera passed into the lungs to collect bronchoalveolar lavage, bronchosorption, bronchial brushings and bronchial biopsies.
8. To repeat these procedures at later time - expected once per year or at times of clinically relevant changes

Conditions

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COPD Asthma Airway Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Airways Disease

Patients with or suspected airways disease including COPD or asthma

No interventions assigned to this group

Healthy Volunteers

Participants with no significant illness

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Participant is willing and able to give informed consent for participation in the study
* Aged 18 years or above
* Patient: known or suspected airway disease
* Healthy volunteer: considered to be in good health with no significant comorbidity (immune disorder, cancer etc.)

Exclusion Criteria

* Known or suspected current pulmonary tuberculosis, HIV (human immunodeficiency virus), Hepatitis B Virus, Hepatitis C Virus.
* Surgery within the preceding 6 weeks
* Participants who are pregnant
* History of psychiatric, medical, or surgical disorders that in the opinion of the chief investigator may interfere with sample collection, undergo a bronchoscopy, or may compromise study completion or data collection
* Alcohol or recreational drug abuse
* Diagnosis of immunodeficiency requiring treatment
* Unable to provide written informed consent
* Unable to read or write English
* Be considered, in the opinion of the investigator, to be an unsuitable candidate for the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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King's College London

OTHER

Sponsor Role collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mona Bafadhel, Prof

Role: PRINCIPAL_INVESTIGATOR

GSTT and KCL

Locations

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Guy's & St Thomas' NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Gillian Radcliffe, MRes

Role: CONTACT

02071888070

Steven Cass, PhD

Role: CONTACT

Facility Contacts

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Gill Radcliffe

Role: primary

02071888070

Other Identifiers

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322540

Identifier Type: -

Identifier Source: org_study_id

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